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ISIS's CEO, Stanley Crooke stated during their annual presentation that IBIS is transitioning from a research to a revenue generating division with the intention of spinning it off. They anticipate revenues to ramp-up quickly and estimate up to $150 million by 2010 just from the sale of the assay kits.
This division could support the entire clinical development program and I can't imagine how much they can sell it for. They can't hold the share price down for much longer.
I think its a hedge fund whose manipulating the price and smaller day traders. With such a low volume stock a big player can sit back, watch the trading, and then decide whether to dump some shares & buy lower or ride it up if the stock has buying pressure. Looks like easy money if you had a sizable position.
You can swing the stock 50 cents or more either way with 20K shares.
DNDN- Your convinced that Provenge shows efficacy, the advisory panel displayed this with their vote, and the FDA only issued an approvable letter due to political and financial pressures by doctors and pharms scared that immunotherapy would become the next standard of care.
Its interesting that MRK did not run into problems gaining FDA approval for Gardasil. Look at all the dollars left on the table because these females will not develop cervical cancer.
I know there is alot of argument that no one would be hurt by the approval. I disagree, it sets a bad precedent that outside interests could pressure the agency into adopting a favorable decision.
The FDA requires substantial evidence of efficacy for approval. The Provenge results do not support this conclusion and thats the only reason the FDA is asking for additional support.
The 13-4 vote was for not for the question of "substantial evidence of efficacy", but rather for "Is there substantial evidence the product is efficacious". So the advisory panel was voting that Provenge was capable of producing a positive effect not that Provenge showed substantial evidence as required by the FDA guidelines.
I know its impossible to look past the conspiracy theories, but its alot simpler, FDA needs more data. The FDA has written/formalized guidelines for approval for this very reason and they would have to change them based on outside pressure to grant Provenge approval.
DNDN, I think it all boils down to questionable efficacy. Provenge may be safe, but it also costs thousands for each pt. treated. Its the FDA's responsibility to not approve drugs which may not work. Provenge was going to cost insurance companies and governmental agencies billions for something that may have been no better then water. The Dendrities can argue the point, but the FDA has the last word.
Options - What do you mean "the Aug $7.50 puts have substantial value"?
I don't follow the options. Do you mean there inexpensive since the market anticipates the stock moving up. I see the open interest as 1,890 contracts. Are these buyers just hedging their position.
Its pretty apparent that anytime you increase T levels then you would get an increase in libido in the study populations. RPRX knows that androxal will show positive QOL in hypogonadal men, but why risk the chance of not achieving stat. significant results if its not necessary for approval.
I'm sure Auxilium plans on emphasizing their QOL benefits unless RPRX does a head to head comparison, but its not necessary. Androxal will become the leader with or without QOL study data.
We both know JP has a hard time keeping quiet, but that doesn't bother me as long as he meets the goals he's laid out. Trains headed to $20.00.
Good job today guys. It was fun watching the trading up to $13.43 and now we have a $14 AH print. Last time we had news the stock had a run on the prior day so maybe somethings coming tomorrow.
Hearing Piper Jaffray, initiated with an outperform and target of $16. From briefing,com.
Dawson and James, mentioned ANX this morning, Briefing.com. One of their favorite plays. "Firm believes ANX's Co-factor may reduce the incidence of chemotherapy-induced anemia in Solid Tumor Cancers".
Congrats for the being named moderator,Learning2vest. LOL. I don't know whether you had time to listen to some of the recent webcasts, but it sounds like the diagnostic division is also starting to heat up.
My 3rd. qtr prediction may have been a little optimistic after reviewing managements timelines, but I think its a possibility. Management stated the 4th qtr 2007 or early 2008 during the 5/17 Annual stockholders meeting.
Management has stated that the inflection point has been reached to maximize value of ISIS 301012. Prior to this point they would not entertain offers, but they are now ready to review term sheets and begin the auction process. There are many companies that want to participate in the negotiations, but there is really only a handful of companies which ISIS would consider partnering with.
They want to license ISIS 301012 prior to Initiating Phase III polygenic studies. They are ready to meet with the FDA to finalize the Phase III study design and they want to file the NDA in late 2008. If they are planning to conduct the polygenic study and submit the NDA prior to 2009 then they need to get the negotiations finalized as soon as possible.
The small number of companies which ISIS would consider as a licensing partner and the need to get the negotiations completed makes me think that its sooner rather then later. I'm sure any parter would also want to be involved in the Phase III trial design so this also pushes ISIS to speed up the negotiation process.
My biggest holdings SGEN, RPRX have put some nice coin in my pocket lately, but I'm getting hurt by a few stocks. CRGN is killing me, new 52 week low because institutions/investors were unhappy with how much they sold their sequencing division. The stock has dropped almost 40%, no negative clinical data, and CRGN made a 100% return on their original sequencing investment. Management has made a decision to concentrate on their current pipeline (3 drugs Phase II) and they have 3 yrs. cash.
I'm also down on MGRM, I bought before the positive advisory panel's decision on maraviroc, PFE's new HIV drug. MGRM is the only company able to provide the assay necessary to optimize pt. selection for maraviroc. The stocks down from $2.20 - $1.60 after the positive news. Only thing I've been able to figure out is that one or more institutions used the news to reduce their position.
So thats two stocks punishing me without any real negatives and I won't even mention SIGA, both look like buys to me, but what do I know since I'm a bagholder.
I wish you had mentioned your option expiration theory when RPRX was trading above $13. I may have swung a few shares. I was doing a little back of the napkin work on what RPRX's marketcap should be at this stage of development and I came up with a $20 shareprice. Thats my target before any buy-out or licensing deals.
Oh yea, AIS is holding up nicely, did you buy any shares?
I think the biggest reason press releases like today's do not lift the stock more is due to the small number of study participants. Management has already stated that the trial sizes can be small since every person enrolled achieves statistically significant reductions in LDL-cholesterol.
Yes, ISIS 301012 is a slam dunk. Management stated in their May/14th update that they are contacted every week by big Pharma asking to partner. I'm hoping PFE partners and we get a $100 million upfront payment. I'm looking for new highs as we get closer to finalizing the deal in the 3rd qtr.
I think Nerf gave the most recent update:
Posted by: Nerf
In reply to: None
Date:4/25/2007 7:38:28 AM
Post #of 351
RPRX-
A brief talk with JP (CEO) revealed that the time frame has slowed slightly, getting data from Europe is a little slower than it might be, but we're on track to hear Endometriosis final report during May, and Androxal final report, in June. Safety data on the endometrial thickening/ hyperplasia with atypia "QUOTE"will be more of the same. there will be thickening, as there always will be but we deal with this by upping the dose, and taking a 4/2 approach to dosing, let the woman menstruate, and begin the program again. There is virtually no cancer risk with this drug"ENDQUOTE" we should see safety data report by mid/late june. The meeting with FDA for androxal endpoints should be August, and (this was either his opinion or my read on what he said) if the endpoint is ONLY increased T, there will be some very active bidders for the drug almost immediately.
Warning: News@Nature - I have been trying for several weeks to cancel my subscription with this website. Their e-mail links do not work for canceling your service, when you call they tell you they need an e-mail to cancel and then they don't confirm receipt of your e-mail notice.
I e-mailed them again today and they confirmed an incident, but of course they haven't canceled my subscription. I'm just waiting for a notice that they have increased my monthly rate.
I've finally realized there is nothing harder to invest in then Bio-techs. Big players have inside information(see IMCL), the manipulation by shorts, small investors get scared, and the lack of news continually pressures the stocks.
I hope interest rates go up so that I can buy some nice CD's and relax.
I wonder if they loaded up in anticipation of a release before todays meeting. If they drop it tomorrow I'll be on the bid.
What a lousy day, down 54 cents on 108K shares. Hope someone can brighten my mood with an update from the meeting.
I don't think anyone is buying AIS due to LibiGel. They have enough catalysts without the FSD approval. If TEVA brings three products to market using their injection system or they can develop Anturol to market then AIS is extremely undervalued. LibiGel would just be icing on the cake.
I just looked in my Yahoo mailbox and someone sent the new Oppenheimer analyst report for AIS. E-mail me "Bio_pete@yahoo.com" if you want me to forward it to you.
Spartex, I've been in AIS since $1.00 and I know RJF had shares at one time. They have three separate un-named commercial deals with TEVA products, one of which should come to market in 2007 for their injection system. I'm expecting this to be pushed back to 2008.
Anturol for overactive bladder has shown positive therapeutic results with reduced adverse events in comparison to oral and patch formulations. They will be initiating 12 week studies this year measuring the number of incontinence episodes. $4 billion urinary incontinence market.
Antares has the rights to the NDA filed for Elestrin and has the rights to market Elestrin in other parts of the world. Elestrin is a 50% lower dosage of currently approved estrogen therapies. Bradley expects to market Elestrin in the U.S. by mid-2007. AIS will receive milestone payments which could amount up to $13 million and royalties upon commercialization.
I wouldn't be surprised to see the shares slide back to the $1.70 area, but the company is a pretty safe play if you want to start taking a position. They have enough cash to fund the operations and management has stated they would be cash flow positive at some point this year. Biggest problem is management salaries and options. There is no near term catalyst unless TEVA makes an announcement. Company is a buy-out target in my opinion.
>>>>>>five companies with more than $2B in annual revenues from generic drugs, investors need a name to describe the major players in this arena. Does anyone have a suggestion?
Generic legal beagles
I wish someone could explain Frontpoint Partners decision to exit their position entirely. 13G filed. If you've made a nice gain why not hold onto a reduced position. Hopefully a stronger player has bought their shares.
I asked Matt to place the ISIS board under biotechs to see if we could get some more investor interest, hope nobody is offended. Looks like I need to see if he will move it from under the bb heading.
I'd appreciate it if you could move it to "Biotechs". Might help to generate more posts. Thanks,
Why isn't "ISIS Pharmaceuticals" listed under the biotech board?
Amazing the low level of investor interest in the company. They have one of the most exciting pipelines and research programs of any bio-tech. Huge partnership deal for ISIS 301012 in a few months. Not to mention yesterdays licensing agreement for PCSK9 with BMS.
Traders don't paint the tape if its going to cost them $100.
I've been told that the aftermarket trades are done as a rounding exercise by funds. Say they have been accumulating shares during the day with program trading and they end with 4900 or 5100. They will buy another 100 shares or sell to get 5000 and they don't care about the price.
Watch the crazy spreads and movements on the bid and ask at the EOD. Traders know that the fund may need to buy or sell shares so thats why you get the aftermarket moves.
As far as pre-market. I think its another method to acquire shares. They run it up in pre-market with 100 share trades and then watch as investors sell into the open. If you averaged it out then they may be able to end the day with more shares at a lower avg. then if they started buying at the open and ran the price up.
So both pre-market & after-market trades higher then normal trading hours indicates someone is accumulating. I know under the scenario above you could have an after market sell, but they were still accumulating during the day.
Ok, take it for what its worth.
Don't post sheet like that, some will believe you.
Ok, you have me stumped. 792K shares, what does that mean?
I love this stock. Nice to see any selling, even at these levels met with bargain buyers.
yea, its just killing me. Not
We all know that its impossible for information to not leak into the market if someone is about to make an offer. Buying interest leads me to think something is in the works. Now, if we can just find out if its for Androxal or the whole enchilada.
"Androxal worth $300M to $600M. Really?"
Hey, we can always dream. If Androxal is worth X amount today then it is worth a multiple of that once Qol's become a non-issue since the U.S. market is four times the rest of the world. JP is pretty confident so the best way to maximize shareholder value would be to wait for a FDA decision.
"I believe there is a very high chance that Solvay Pharmaceuticals will step in and buy the Androxal before RPRX can get a response from the FDA"
The question is, does RPRX accept $300 million today for Androxal or $600 million after the FDA says QoL's are not necessary or our 6 month data shows statistically positive distress results?
Worse case scenario is that the FDA requires QoL's and Androxal is still worth $300 million plus. So why in the world would RPRX accept any offer prior to an FDA decision?
Androgel exogenously replaces testosterone. Androxal restores normal testosterone production. Its hard for me to believe that the FDA can look past the benefits of restoring or maintaining testosterone production as opposed to the risks with replacement therapy.
There is absolutely no reason to require QoL. I realize that the FDA does not have to think logically.
Androxal - I just reviewed the CIBC conference. Podolski states that we should know something from the FDA this summer. So maybe we'll know before Sept. about Qol.
I can't remember the details. When are we meeting with the FDA to finalize the primary endpoints necessary for approval of Androxal? Are you saying it going to take till Sept to find out about QoL?